Negative effects of COVID-19 on the implantation rate of cardiac resynchronization therapy with defibrillator device.

Introduction: COVID-19 drastically impacted the landscape of the United States' medical system. Limited data is available on the nationwide implantation trends in Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices before and during the pandemic. We aimed to explore the impact of the COVID-19 pandemic on CRT-D insertion rates and adverse outcomes related to delays in care. Methods and Results: We conducted a retrospective cross-sectional analysis using the National Inpatient Sample database between 2017 and 2020. Variables were identified using their ICD-10 codes. Inclusion criteria: age ≥ 18 years, presenting for a nonelective admission, primary diagnosis of hypertensive heart disease, hypertensive heart, chronic kidney disease, or heart failure, and underwent insertion of a CRT-D. Between 2017 and 2020, CRT-D devices were inserted during 23,635 admissions. On average, 6198 devices were implanted yearly from 2017 to 2019, with only 5040 devices being implanted in 2020. Additionally, reduced implantation rates were noted for every cohort of hospital size, location, and teaching status during this year. The year 2020 also had the highest average death rate at 1.39%, but this difference was statistically insignificant (adjusted Wald test p = .767), and COVID-19 was not associated with an increased risk of inpatient mortality (OR 0.22, 95% CI 0.03-1.82, p = .162). Conclusion: The COVID-19 pandemic has affected all facets of the healthcare system, especially surgical volume rates. CRT-D procedures significantly decreased in 2020. This is the first retrospective study highlighting the trend of reduced rates of CRT-D implantation as a response to the COVID-19 pandemic.

Intention to use physical restraint in paediatric intensive care units and correlated variables: A multicentre and cross-sectional study.

OBJECTIVES: To determine the intention to use physical restraint (PR) and the relationship with sociodemographic and professional variables of the Paediatric Intensive Care Unit (PICU) nurses. RESEARCH METHODOLOGY/DESIGN AND SETTING: A multicentre and correlational study was carried out from October 2021 to December 2023 in five paediatric intensive care units from five maternal and child hospitals in Spain. The Paediatric Physical Restraint-Theory of Planned Behaviour Questionnaire was provided. Moreover, sociodemographic and employment variables were registered. RESULTS: A total of 230 paediatric nurses participated in the study. A total of 87.7 % were females with an average age of 35.5 ± 9.7 years and working experience of 10.5 ± 8.4 years. The mean scores obtained were 21.1 ± 3.8 for attitude, 13.1 ± 5.0 for subjective norms, 14.4 ± 4.3 for perceived behavioural control and 28.0 ± 6.0 for intention. The nurses apply more physical restraint to anxious patients, with scarce analgesics and sedation, those affected with pharmacological withdrawal symptoms and those with a high risk of accidental removal of vital support devices or fall from bed. The sex (p = 0.007) and type of employment contract (p = 0.01) are the variables that are significantly correlated with the intention to use of PR. CONCLUSION: The paediatric nurses analysed had a moderate attitude, social pressure and perceived behavioural control towards the use of PR. IMPLICATIONS FOR CLINICAL PRACTICE: It is important to know the factors that influence the intention to use physical restraint in order to standardise safe practice for critically ill paediatric and to ensure that patients' rights are respected by obtaining informed consent and assessing the prescription, continuation and removal of physical restraint.

Current Trends in Hypertension Identification and Management: Insights from the National Health and Nutrition Examination Survey (NHANES) Following the 2017 ACC/AHA High Blood Pressure Guidelines.

BACKGROUND: Hypertension is a global health issue associated with increased cardiovascular morbidity and mortality. This study aimed to investigate contemporary hypertension identification and management trends following the 2017 American College of Cardiology/American Heart Association guidelines. METHODS AND RESULTS: Data from the National Health and Nutrition Examination Survey conducted from 2017 to 2020 were analyzed. Participants between 20 and 79 years of age were included. Participants were stratified into different treatment groups based on indication and guideline adherence. Descriptive statistics were used to compare medication use, diagnosis rates, and blood pressure control. A total of 265 402 026 people met the inclusion criteria, of which 19.0% (n=50 349 209) were undergoing guideline antihypertensive management. In the guideline antihypertensive management group, a single antihypertensive class was used to treat 45.7% of participants, and 55.2% had uncontrolled blood pressure. Participants not undergoing guideline antihypertensive management qualified for primary prevention in 11.5% (n=24 741 999) of cases and for secondary prevention in 2.4% (n=5 070 044) of cases; of these, 66.3% (n=19 774 007) did not know they may have hypertension and were not on antihypertensive medication. CONCLUSIONS: Adherence to guidelines for antihypertensive management is suboptimal. Over half of patients undergoing guideline treatment had uncontrolled blood pressure. One-third of qualifying participants may not be receiving treatment. Education and medical management were missing for 2 in 3 qualifying participants. Addressing these deficiencies is crucial for improving blood pressure control and reducing cardiovascular event outcomes.

Long-term impact of COVID-19 pandemic on antibiotic use in primary care: lessons to optimize antimicrobial use.

BACKGROUND: Lockdowns due to the COVID-19 pandemic was associated with changes in the pattern of use of antimicrobials, but persistence of changes after lockdowns has not been described. The objective was to describe the number of patients with dispensed antibiotic treatment and consumption of antibiotics in outpatients from primary care in Catalonia 18 months after the end of the emergency period. RESEARCH DESIGN AND METHODS: Data for the COVID-19 pandemic period was obtained from March 2020 to December 2021. Four high transmission rate (Rt > 100) periods were established. To compare data, a simple Bayesian structural time series model was used. RESULTS: The observed number of patients with dispensed antibiotics decreased respect to the estimated, especially during the four high transmission rate periods: April-May 2020 (lockdown period) (-42.57% and -42.68%); December 2020-February 2021 (-41.65%, -49.97% and -43.64%); October 2021 (-16.23%), and December 2021 (-20.16%). Overall antibiotic consumption was reduced by 23.37% (p = 0.002). These differences were mainly observed in those ≤ 15 years. CONCLUSIONS: We describe the reduction in the number of patients with dispensed antibiotics and antibiotic consumption after the COVID-19 lockdown persisted in a period of recovery of healthcare accessibility. This information may help to improve antimicrobial use at the primary care level.

Adaptation and validation of the Physical Restraint-Theory of Planned Behaviour Questionnaire to the paediatric context.

OBJECTIVE: To create and test psychometrically a paediatric version of the Physical Restraint-Theory of Planned Behaviour Questionnaire to assess paediatric critical care nurses' intention to use physical restraint. DESIGN: A psychometric study. SETTING: Five medical-surgical Paeditric Intensive care Units from five hospitals in Spain. METHODS: The study took place in three phases. In phase 1, the questionnaire was adapted. In phase 2, the content validity of each item was determined, and a pilot test was conducted. In phase 3, we administered the questionnaire and determined its psychometric properties. RESULTS: The assessment of the intention to use physical restraint was extended to all critical paediatric patients, two items were eliminated from the initial questionnaire, four new items were included, and the clinical scenarios of the intention subscale were expanded from three to six. Overall content validity index for the full instrument of 0.96 out of 1. The Paediatric Physical Restraint-Theory of Planned Behaviour Questionnaire is made up of four subscales (attitude, subjective norms (SN), perceived behavioural control (PBC), and intention) subdivided into 7 factors and 51 items. The internal consistency for the attitude subscale obtained a Cronbach's Alpha of 0.80 to 0.73, for the SN it was 0.72 to 0.89, for the PBC it was from 0.80 to 0.73 and for the intention subscale it was 0.75. CONCLUSIONS: The Paediatric Physical Restraint-Theory of Planned Behaviour Questionnaire is an instrument composed of seven factors and 51 items that validly and reliably assesses the intention of paediatric nurses to apply PR in PICUs. RELEVANCE FOR CLINICAL PRACTICE: Having this instrument will help health centres move towards restraint-free care by allowing managers to assess professionals' attitudes, beliefs, and intentions around the use of PR in PICUs.

Geographic variability and operator trends of transcatheter edge-to-edge repair in the United States.

BACKGROUNDS: Transcatheter edge-to-edge repair (TEER) devices are used for primary mitral regurgitation (MR) and secondary MR. Despite the growing use of TEER devices, there have not been many studies on operator experience or procedure volumes by state. AIMS: We aimed to investigate nationwide operator volume trends and geographic variation in access to TEER. METHODS: The United States Center for Medicare and Medicaid Services (CMS) National Medicare Provider Utilization and Payment Database (MPUPD) was analyzed between 2015 and 2020 for initial TEER procedures. RESULTS: Procedure volume and total operators increased yearly from 2015 to 2019 but declined in 2020. Mean annual procedure volume per operator varied significantly by state, between 0 in multiple states and 35 in North Dakota. In 2019, 994 unique operators were identified, with 295 operators documented performing 10 or more procedures (29.68%). Operators performing 10 or more TEER procedures provided 68.46% of all operations in 2019, averaging 20.94 procedures per operator. CONCLUSIONS: TEER procedures are becoming increasingly common as more operators are being trained. However, significant variability exists in the procedural volume per operator.

Sex-based differences in left ventricular assist device clinical outcomes.

BACKGROUND: Heart failure (HF) continues to be a significant public health issue, posing a heightened risk of morbidity and mortality for both genders. Despite the widespread use of left ventricular assist device (LVAD), the influence of gender differences on clinical outcomes following implantation remains unclear. OBJECTIVES: We investigated the impact of gender differences on readmission rates and other outcomes following LVAD implantation in patients admitted with advanced HF. METHODS: We conducted a retrospective study of patients who underwent LVAD implantation for advanced HF between 2014 and 2020, using the Nationwide Readmissions Database. Our study cohort was divided into male and female patients. The primary outcome was 30-day readmission (30-dr), while secondary outcomes were inpatient mortality, length of stay (LOS), procedural complication rates, and periadmission rates. Multivariate linear, Cox, and logistic regression analyses were performed. RESULTS: During the study period, 11,492 patients with advanced HF who had LVAD placement were identified. Of these, 22% (n = 2532) were females and 78% (n = 8960) were males. The mean age was 53.9 ± 10.8 years for females and 56.3 ± 10.5 years for males (adjusted Wald test, p < 0.01). Readmissions were higher in females (21% vs. 17%, p = 0.02) when compared to males. Cox regression analysis showed higher readmission events (hazard ratio: 1.24, 95% confidence interval: 1.01-1.52, p = 0.03) in females when compared to males. Inpatient mortality, LOS, and most procedural complication rates were not statistically significantly different between the two groups (p > 0.05, all). CONCLUSION: Women experienced higher readmission rates and were more likely to be readmitted multiple times after LVAD implantation when compared to their male counterparts. However, there were no significant sex-based differences in inpatient mortality, LOS, and nearly all procedural complication rates. These findings suggest that female patients may require closer monitoring and targeted interventions to reduce readmission rates.

Mediterranean diet and epicardial adipose tissue in patients with atrial fibrillation treated with ablation: a substudy of the 'PREDIMAR' trial.

AIMS: To analyse the relationship between Mediterranean diet (MedDiet) adherence and epicardial adipose tissue (EAT) in patients with atrial fibrillation (AF) and the association between EAT or MedDiet adherence at baseline with AF recurrence after ablation. METHODS AND RESULTS: We included 199 patients from the PREDIMAR trial (PREvención con DIeta Mediterránea de Arritmias Recurrentes), in a single centre in this substudy. All of them had a computed tomography with EAT measurement. Lifestyle and clinical characteristics were obtained at baseline. The traditional MedDiet pattern was defined according to the MedDiet Adherence Screener (MEDAS). Any documented AF > 30 s after ablation was considered a recurrence. Multivariable-adjusted linear and logistic regression models were run to assess the cross-sectional association of MedDiet with EAT, and of EAT with the AF type at baseline. Also, Cox regression models were used to prospectively assess the associations of MedDiet adherence and EAT with AF recurrences after ablation. Median EAT was 135 g (interquartile range: 112-177), and the mean MedDiet score was 7.75 ± 2 points. A higher MEDAS ≥ 7 that was associated with lower odds of an EAT ≥ 135 g [multivariable odds ratio (mOR) = 0.45; 95% CI = 0.22-0.91; P = 0.025] was significantly associated with persistent AF after adjusting for traditional risk factors (mOR: 2.22; 95% CI: 1.03-4.79; P = 0.042). No significant associations were observed between EAT ≥ 135 g and the risk of atrial tachyarrhythmia recurrences after ablation [multivariable-adjusted hazard ratio (mHR) = 1.18; 95% CI: 0.72-1.94; P = 0.512], or between MEDAS ≥ 7 and AF recurrence (mHR = 0.78; 95% CI: 0.47-1.31; P = 0.344). CONCLUSION: In patients with AF, higher adherence to MedDiet is associated with a significantly lower amount of EAT. Epicardial adipose tissue ≥ 135 g was significantly associated with persistent AF.

Mediterranean diet consumption is significantly associated with a lower amount of epicardial adipose tissue in patients with atrial fibrillation treated with ablation. A higher amount of epicardial adipose tissue is significantly associated with a persistent pattern of atrial fibrillation that is well known as a more aggressive and difficult to treat type of atrial fibrillation. The risk of arrhythmic recurrence after ablation tended to be associated with a larger amount of epicardial adipose tissue. Adherence to Mediterranean diet is associated with a non-significantly lower risk of arrhythmic recurrences after ablation.

Impact of Frailty on Left Ventricular Assist Device Clinical Outcomes.

Frailty is a clinical syndrome prevalent in older adults and carries poor outcomes in patients with heart failure. We investigated the impact of frailty on left ventricular assist device (LVAD) clinical outcomes. The Nationwide Readmission Database was used to retrospectively identify patients with a primary diagnosis of heart failure who underwent LVAD implantation during their hospitalization from 2014 to 2020. Patients were categorized into frail and nonfrail groups using the Hospital Frailty Risk Score. Cox and logistic regression were used to predict the impact of frailty on inpatient mortality, 30-day readmissions, length of stay, and discharge to a skilled nursing facility. LVADs were implanted in 11,465 patients who met the inclusion criteria. There was more LVAD use in patients who were identified as frail (81.6% vs 18.4%, p <0.001). The Cox regression analyses revealed that LVAD insertion was not associated with increased inpatient mortality in frail patients (hazard ratio 1.15, 95% confidence interval 0.81 to 1.65, p = 0.427). Frail patients also did not experience a higher likelihood of readmissions within 30 days (hazard ratio 1.15, 95% confidence interval 0.91 to 1.44, p = 0.239). LVAD implantation did not result in a significant increase in inpatient mortality or readmission rates in frail patients compared with nonfrail patients. These data support continued LVAD use in this high-risk patient population.

Enhancing the Hydrolytic Activity of a Lipase towards Larger Triglycerides through Lid Domain Engineering.

Lipases have valuable potential for industrial use, particularly those mostly active against water-insoluble substrates, such as triglycerides composed of long-carbon chain fatty acids. However, in most cases, engineered variants often need to be constructed to achieve optimal performance for such substrates. Protein engineering techniques have been reported as strategies for improving lipase characteristics by introducing specific mutations in the cap domain of esterases or in the lid domain of lipases or through lid domain swapping. Here, we improved the lipase activity of a lipase (WP_075743487.1, or LipMRD) retrieved from the Marine Metagenomics MarRef Database and assigned to the Actinoalloteichus genus. The improvement was achieved through site-directed mutagenesis and by substituting its lid domain (FRGTEITQIKDWLTDA) with that of Rhizopus delemar lipase (previously R. oryzae; UniProt accession number, I1BGQ3) (FRGTNSFRSAITDIVF). The results demonstrated that the redesigned mutants gain activity against bulkier triglycerides, such as glyceryl tridecanoate and tridodecanoate, olive oil, coconut oil, and palm oil. Residue W89 (LipMRD numbering) appears to be key to the increase in lipase activity, an increase that was also achieved with lid swapping. This study reinforces the importance of the lid domains and their amino acid compositions in determining the substrate specificity of lipases, but the generalization of the lid domain swapping between lipases or the introduction of specific mutations in the lid domain to improve lipase activity may require further investigation.

Unveiling the Connectivity of Complex Networks Using Ordinal Transition Methods.

Ordinal measures provide a valuable collection of tools for analyzing correlated data series. However, using these methods to understand information interchange in the networks of dynamical systems, and uncover the interplay between dynamics and structure during the synchronization process, remains relatively unexplored. Here, we compare the ordinal permutation entropy, a standard complexity measure in the literature, and the permutation entropy of the ordinal transition probability matrix that describes the transitions between the ordinal patterns derived from a time series. We find that the permutation entropy based on the ordinal transition matrix outperforms the rest of the tested measures in discriminating the topological role of networked chaotic Rössler systems. Since the method is based on permutation entropy measures, it can be applied to arbitrary real-world time series exhibiting correlations originating from an existing underlying unknown network structure. In particular, we show the effectiveness of our method using experimental datasets of networks of nonlinear oscillators.

Deterministic and stochastic cooperation transitions in evolutionary games on networks.

Although the cooperative dynamics emerging from a network of interacting players has been exhaustively investigated, it is not yet fully understood when and how network reciprocity drives cooperation transitions. In this work, we investigate the critical behavior of evolutionary social dilemmas on structured populations by using the framework of master equations and Monte Carlo simulations. The developed theory describes the existence of absorbing, quasiabsorbing, and mixed strategy states and the transition nature, continuous or discontinuous, between the states as the parameters of the system change. In particular, when the decision-making process is deterministic, in the limit of zero effective temperature of the Fermi function, we find that the copying probabilities are discontinuous functions of the system's parameters and of the network degrees sequence. This may induce abrupt changes in the final state for any system size, in excellent agreement with the Monte Carlo simulation results. Our analysis also reveals the existence of continuous and discontinuous phase transitions for large systems as the temperature increases, which is explained in the mean-field approximation. Interestingly, for some game parameters, we find optimal "social temperatures" maximizing or minimizing the cooperation frequency or density.

Intracardiac leadless versus transvenous permanent pacemaker implantation: Impact on clinical outcomes and healthcare utilization.

BACKGROUND: Transvenous permanent pacemakers are used frequently to treat cardiac rhythm disorders. Recently, intracardiac leadless pacemakers offer potential treatment using an alternative insertion procedure due to their novel design. Literature comparing outcomes between the two devices is scarce. We aim to assess the impact of intracardiac leadless pacemakers on readmissions and hospitalization trends. METHODS: We analyzed the National Readmissions Database from 2016 to 2019, seeking patients admitted for sick sinus syndrome, second-degree-, or third-degree atrioventricular block who received either a transvenous permanent pacemaker or an intracardiac leadless pacemaker. Patients were stratified by device type and assessed for 30-day readmissions, inpatient mortality, and healthcare utilization. Descriptive statistics, Cox proportional hazards, and multivariate regressions were used to compare the groups. RESULTS: Between 2016 and 2019, 21,782 patients met the inclusion criteria. The mean age was 81.07 years, and 45.52 % were female. No statistical difference was noted for 30-day readmissions (HR 1.14, 95 % CI 0.92-1.41, p = 0.225) and inpatient mortality (HR 1.36, 95 % CI 0.71-2.62, p = 0.352) between the transvenous and intracardiac groups. Multivariate linear regression revealed that length of stay was 0.54 (95 % CI 0.26-0.83, p < 0.001) days longer for the intracardiac group. CONCLUSION: Hospitalization outcomes associated with intracardiac leadless pacemakers are comparable to traditional transvenous permanent pacemakers. Patients may benefit from using this new device without incurring additional resource utilization. Further studies are needed to compare long-term outcomes between transvenous and intracardiac pacemakers.

Increased Thermostability of an Engineered Flavin-Containing Monooxygenase to Remediate Trimethylamine in Fish Protein Hydrolysates.

Protein hydrolysates made from marine by-products are very nutritious but frequently contain trimethylamine (TMA), which has an unattractive fish-like smell. Bacterial trimethylamine monooxygenases can oxidize TMA into the odorless trimethylamine N-oxide (TMAO) and have been shown to reduce TMA levels in a salmon protein hydrolysate. To make the flavin-containing monooxygenase (FMO) Methylophaga aminisulfidivorans trimethylamine monooxygenase (mFMO) more suitable for industrial application, we engineered it using the Protein Repair One-Stop Shop (PROSS) algorithm. All seven mutant variants, containing 8 to 28 mutations, displayed increases in melting temperature of between 4.7°C and 9.0°C. The crystal structure of the most thermostable variant, mFMO_20, revealed the presence of four new stabilizing interhelical salt bridges, each involving a mutated residue. Finally, mFMO_20 significantly outperformed native mFMO in its ability to reduce TMA levels in a salmon protein hydrolysate at industrially relevant temperatures. IMPORTANCE Marine by-products are a high-quality source for peptide ingredients, but the unpleasant fishy odor caused by TMA limits their access to the food market. This problem can be mitigated by enzymatic conversion of TMA into the odorless TMAO. However, enzymes isolated from nature must be adapted to industrial requirements, such as the ability to tolerate high temperatures. This study has demonstrated that mFMO can be engineered to become more thermostable. Moreover, unlike the native enzyme, the best thermostable variant efficiently oxidized TMA in a salmon protein hydrolysate at industrial temperatures. Our results present an important next step toward the application of this novel and highly promising enzyme technology in marine biorefineries.

Cross-Sectional Survey on the Current Role of Clinical Pharmacists among Antimicrobial Stewardship Programmes in Catalonia: Much Ado about Nothing.

BACKGROUND: Antimicrobial resistance killed 1.27 million people in 2019, so urgent actions are desperately needed. Antimicrobial stewardship programmes (ASPs) are essential to optimize antimicrobial use. The objective was to acknowledge the current role of clinical pharmacists engaged in ASP activities in Catalonia. METHODS: This was a cross-sectional survey shared through the Catalan Infection Control Programme (VINCat). The survey consisted of four sections and was sent by e-mail. RESULTS: A total of 69.0% of the centres answered. Pharmacists dedicated a median of 5.0 h per week (2.1 h/week/100 acute care beds), representing 0.15 full time equivalents. The ASP lacked information technology (IT) support, as only 16.3% of centres automatically calculated defined daily doses and days of therapy. Those with less than 15% of their time available for ASPs conducted fewer clinical activities, especially prospective audits and feedback. Those without official infectious diseases training also performed fewer clinical activities, but training was less determinant than IT support or time. Pharmacists performed interventions mostly through annotation in the medical records. CONCLUSIONS: Clinical pharmacists from Catalonia dedicated to ASPs present an important lack of time and IT support to perform clinical activities. Pharmacists should also improve their clinical skills and try to conduct clinical advice to prescribers, either by phone or face-to-face.

Leveraging a nationwide infection surveillance program to implement a colorectal surgical site infection reduction bundle: a pragmatic, prospective, and multicenter cohort study.

BACKGROUND: Bundled interventions usually reduce surgical site infection (SSI) when implemented at single hospitals, but the feasibility of their implementation at the nationwide level and their clinical results are not well established. MATERIALS AND METHODS: Pragmatic interventional study to analyze the implementation and outcomes of a colorectal surgery care bundle within a nationwide quality improvement program. The bundle consisted of antibiotic prophylaxis, oral antibiotic prophylaxis (OAP), mechanical bowel preparation, laparoscopy, normothermia, and a wound retractor. Control group (CG) and Intervention group (IG) were compared. Overall SSI, superficial (S-SSI), deep (D-SSI), and organ/space (O/S-SSI) rates were analyzed. Secondary endpoints included microbiology, 30-day mortality, and length of hospital stay. RESULTS: A total of 37 849 procedures were included, 19 655 in the CG and 18 194 in the IG. In all, 5462 SSIs (14.43%) were detected: 1767 S-SSI (4.67%), 847 D-SSI (2.24%), and 2838 O/S-SSI (7.5%). Overall SSI fell from 18.38% (CG) to 10.17% (IG), odds ratio (OR) of 0.503 [0.473-0.524]. O/S-SSI rates were 9.15% (CG) and 5.72% (IG), OR of 0.602 [0.556-0.652]. The overall SSI rate was 16.71% when no measure was applied and 6.23% when all six were used. Bundle implementation reduced the probability of overall SSI (OR: 0.331; CI 95 : 0.242-0.453), and also O/S-SSI rate (OR: 0.643; CI 95 : 0.416-0.919). In the univariate analysis, all measures except normothermia were associated with a reduction in overall SSI, while only laparoscopy, OAP, and mechanical bowel preparation were related to a decrease in O/S-SSI. Laparoscopy, wound retractor, and OAP decreased overall SSI and O/S-SSI in the multivariate analysis. CONCLUSIONS: In this cohort study, the application of a specific care bundle within a nationwide nosocomial infection surveillance system proved feasible and resulted in a significant reduction in overall and O/S-SSI rates in the elective colon and rectal surgery. The OR for SSI fell between 1.5 and 3 times after the implementation of the bundle.

XEN Gel Stent Versus Nonpenetrating Deep Sclerectomy in Ocular Hypertension and Open Angle Glaucoma Patients.

PRCIS: XEN gel stent and nonpenetrating deep sclerectomy, both either alone or in combination with cataract surgery, significantly lowered the intraocular pressure (IOP) and reduced the number of antiglaucoma medications in patients with open angle glaucoma, with no significant differences between them. PURPOSE: To compare the surgical outcomes of XEN45 implant and nonpenetrating deep sclerectomy (NPDS), either alone or in combination with cataract surgery, in patients with ocular hypertension and open angle glaucoma (OAG). A retrospective and single-center cohort study was conducted on consecutive patients who underwent a XEN45 implant or an NPDS, either alone or in combination with phacoemulsification. The primary endpoint was the mean change in IOP from the baseline to the last follow-up visit. One hundred twenty-eight eyes, 65 (50.8%) eyes in the NPDS group and 63 (49.2%) eyes in the XEN group, were included in the study. The mean preoperative IOP was significantly lowered from 17.6±5.3 mm Hg and 17.8±6.2 mm Hg to 12.6±2.6 mm Hg and 13.8±2.8 mm Hg at month 12 in the XEN and NPDS groups, respectively; P <0.0001 each. At month 12, 70 (54.7%) eyes were classified as a success, with no significant differences between XEN (57.1%; 36/63 eyes) and NPDS (52.3%; 34/65 eyes) (mean difference: 4.8%; 95% CI: -30.5% to 20.8%; P =0.7115). The number of ocular hypotensive medications was significantly reduced in the XEN (from 2.1±0.7-0.2±0.5, P <0.0001) and in the NPDS (from 2.0±0.8 to 0.3±0.6, P <0.0001) groups, with no significant differences between them ( P =0.2629). The incidence of postoperative adverse events in the overall study population was 12.5%, with no significant differences between groups ( P =0.1275). Seven (11.1%) eyes underwent needling (XEN group) and 10 (15.4%) goniopuncture (NPDS group); P =0.4753. CONCLUSIONS: XEN45 implant and the NPDS, either alone or in combination with cataract surgery, significantly lowered IOP and reduced the number of ocular hypotensive medications in ocular hypertension and patients with open angle glaucoma.